- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096301
Photobiomodulation in Temporomandibular Disorder
Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lara Motta, PhD
- Phone Number: 5511998829511
- Email: larajmotta@terra.com.br
Study Locations
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brazil, 18130 430
- Recruiting
- Lara Motta
-
Contact:
- Lara Motta, PhD
- Phone Number: 5511998829511
- Email: larajmotta@terra.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- people between 15 and 25 years
- diagnosis of TMD in group I
Exclusion Criteria:
- Individuals with dental-facial anomalies
- orthodontic or orthopedic treatment
- Individuals who were taking muscle relaxants or anti-inflammatory medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-intensity laser
Twelve laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2, in accordance with the protocol suggested by Venezian et al. (2010) and Carvalho et al. (2010).
The laser will be applied to 3 points of the masseter muscle (upper, middle, and lower bundles) and 1 point in the anterior temporalis on each side of the face
|
Laser applications will be applied as initial treatment, with 2 sessions per week.
A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point.
The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
Active Comparator: Occlusal Plate
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment |
Placebo Comparator: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 12 months after treatment
|
Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders
|
12 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectviness
Time Frame: 12 months after treatment
|
This phase of the study will consist in the quantification of resources, i.e. determining the frequency of use of resources and materials during the treatment.
The units used to quantify the direct costs consumed are physical units such as consultation time, number of sessions, equipment used, and materials consumed.
These data will be collected using a specific form.
|
12 months after treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- CEPhotobio01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Low-intensity laser
-
Cairo UniversityNot yet recruitingPrimary Dysmenorrhea
-
Laboratório de Engenharia de Reabilitação Sensorio...Unknown
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento... and other collaboratorsCompleted
-
Fundación Pública Andaluza Progreso y SaludUnknown
-
National Eye Institute (NEI)CompletedMacular DegenerationUnited States
-
Al-Azhar UniversityEnrolling by invitationEffect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by MillimeterEgypt
-
Cairo UniversityKing Khalid UniversityNot yet recruitingChronic Nonspecific Low-back PainEgypt
-
Ankara City Hospital BilkentCompletedCarpal Tunnel Syndrome | Ultrasound Imaging | Electromyography | Low-Level Laser TherapyTurkey
-
Universidade Estadual Paulista Júlio de Mesquita...Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.CompletedDiabetes Mellitus | Chronic Periodontitis
-
University of Sao PauloRecruiting